BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC BIPOLAR 28X54MM

    MDR report key: 5822972 · Received July 26, 2016

    Report

    Report Number
    0001825034-2016-02739
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    March 16, 2016
    Report Date
    September 30, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNONE
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01248 / 02738 / 02739). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051569. DEVICE REQUESTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT EVALUATION RESULTS. (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE AND DEVICE LIKELY LEFT THE MANUFACTURER CONFORMING TO PRINT. DIMENSIONAL ANALYSIS REVEALED THE INNER DIAMETER OF THE POLYETHYLENE INSERT WAS SLIGHTLY LARGER THAN SPECIFICATION; HOWEVER, THIS IS LIKELY THE RESULT OF ASSEMBLY AND SUBSEQUENT DISASSOCIATION OF THE DEVICE. VISUAL EXAMINATION REVEALED TWO AREAS OF DEFORMATION ON THE POLYETHYLENE INSERT, LIKELY FROM NORMAL CONTACT WITH THE FEMORAL STEM. THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS THE ATTACHMENT OF SOFT TISSUE TO THE CUP DURING ATTEMPTS TO REDUCE, CAUSING THE HEAD TO PULL OUT OF THE POLYETHYLENE INSERT; HOWEVER, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A MANIPULATION DUE TO DISLOCATION APPROXIMATELY ONE YEAR POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475821 E1 RINGLOC BIPOLAR 28X54MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 903450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R